A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis

NCT ID: NCT01497119

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-02-29

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.

Detailed Description

This is a randomized (treatment assigned by chance), double-blind (patient and investigator will not know what treatment is being given), multicenter, parallel-group, exploratory study in adult Japanese patients with moderate atopic dermatitis. This study will include 3 phases. In the screening phase, patients' eligibility will be determined. During the treatment phase, eligible patients will receive JNJ-39758979, 300 or 100 mg once daily, or placebo (a treatment that looks like JNJ-39758979, but contains no active agent) for up to 6 weeks. Study visits will occur at the end of Weeks 1, 2, 4, and 6. There will be a follow-up visit 4 weeks after dosing is complete. The duration of participation in the study for an individual patient may be up to 14 weeks (including screening). Patient safety will be monitored throughout the study.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-39758979, 300 mg

Group Type: EXPERIMENTAL

JNJ-39758979, 300 mg

Intervention Type: DRUG

Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.

JNJ-39758979, 100 mg

Group Type: EXPERIMENTAL

JNJ-39758979, 100 mg

Intervention Type: DRUG

Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Form=tablet, route=oral use, once daily for 6 weeks.

Interventions

JNJ-39758979, 300 mg

Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.

Intervention Type: DRUG

JNJ-39758979, 100 mg

Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.

Intervention Type: DRUG

Placebo

Form=tablet, route=oral use, once daily for 6 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of atopic dermatitis based on the criteria of the Japanese Dermatological Association and have: pruritus (itching); eczema-like changes in a typical pattern, and a chronic or chronically relapsing course.
• Childhood onset (under age of 13) of atopic dermatitis.
• Diagnosis of moderate atopic dermatitis based on the Rajka Langeland score between 4.5 and 7.5, inclusive.
• Have at least 3 ratings of "Moderate itching", "Severe itching", or "Extremely severe itching" either at night or during the day based on the Pruritus Categorical Response Scale (PCRS) in the 7 days prior to randomization.
• Atopic dermatitis with 10% to 50% (inclusive) Body Surface Area (BSA) involvement.

Exclusion Criteria

• Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the Investigator's opinion. Patients with well controlled asthma, allergic rhinitis, or allergic conjunctivitis are allowed to participate. Atopic dermatitis patients with other chronic conditions will not be excluded if the Investigator has determined that the condition is not severe or progressive and is being controlled with stable therapy.
• Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent).
• Evidence of any other skin condition that, in the opinion of the Investigator, would interfere with the assessment of atopic dermatitis.
• Use of non-steroid immunosuppressive or immunomodulatory agents within 4 weeks of randomization, including cyclosporine A, azathioprine, mycophenolate mofetil, and interferon gamma.
• Use of systemic corticosteroids within 4 weeks of randomization.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Chitose, , Japan

Dazaifu, , Japan

Ebetsu, , Japan

Eniwa, , Japan

Fukuoka, , Japan

Kasuga, , Japan

Matsudo, , Japan

Saitama, , Japan

Sapporo, , Japan

Setagaya City, , Japan

Tokyo, , Japan

Utsunomiya, , Japan

Yokohama, , Japan

Countries

Japan

Other Identifiers

39758979ADM2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR017455

Identifier Type: -

Identifier Source: org_study_id